Kornimate/medical-research-clean huggingface dataset:
a research study for patients with metastatic renal cell carcinoma

Conditions: Carcinoma, Renal Cell; Neoplasm Metastasis

Summary: the purpose of this study is to evaluate the activity of fk228 in metastatic renal cell carcinoma (rcc) patients who have developed progressive disease (pd) following or during treatment with immunotherapy.


Eligibility criteria:
inclusion criteria: patients must fulfill all of the following criteria to be eligible for study participation: * age ≥ 18 years; * histologically confirmed renal cell carcinoma (rcc); * metastatic disease, with measurable lesions according to the response evaluation criteria in solid tumors (recist); * failure of prior cytokine therapy; * documented progressive disease; exclusion criteria: patients are ineligible for entry if any of the following criteria are met: * significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina * history of serious ventricular arrhythmia * corrected qt interval (qtc) ≥ 500 msec * known infection with human immunodeficiency virus (hiv), hepatitis b, or hepatitis c; * previous extensive radiotherapy involving ≥ 30% of bone marrow * coexistent second malignancy or history of prior malignancy within previous 5 years

Keywords: renal cell carcinoma metastatic cancer metastatic renal cell carcinoma
fructose breath-testing in irritable bowel syndrome (ibs)

Conditions: Functional Gastrointestinal Disorders; Irritable Bowel Syndrome

Summary: background: breath testing for food intolerances is becoming routine in patients with functional gastrointestinal disorders (fgid). both fgid and saccharide intolerances (fodmaps: fermentable oligo-, di-, polysaccharide and polyols, e.g. lactose, fructose, sorbitol) are common (\>10% of any given population) and often respond to dietary modification. the breath tests are based on quantification of gas excretion in breath as a sign of malabsorption and symptom provocation, but are likely subject to considerable psychological bias. the role of expectation and other psychological effects on breath testing has not been reported, but is crucial for the validation of these increasingly wide-spread tests with considerable dietary and potentially deleterious consequences. fructose has been shown to result in short term pro-inflammatory metabolic responses, but these effects have not been studied as underlying causes for intolerance symptoms in fructose intolerant patients with fgid. aim: to investigate the psychological component and the short-term metabolic effects of fructose breath testing in patients referred for evaluation of fgid using placebo. additionally, to assess baseline predictors for a positive breath test result. methods: fructose intolerance (defined by a positive symptom index) and malabsorption (defined by increased breath hydrogen/methane concentrations) will be determined in 30 successive male and female fgid in a single centre using breath-testing. fructose 35g, given double-blind as well as open, a sweet placebo (cyclamate/saccharine; assugrin®) and a neutral (still water) placebo given double-blind will be compared in a randomized, cross-over sequence and according to our standardised procedure on four separate study days. symptoms will be recorded using standardised questionnaires and breath concentrations of h2 and ch4 will be measured during testing on the four study days. somatisation and psychological profiles will be assessed by questionnaires. blood samples will be obtained before and during provocation testing to assess short-term responses to fructose loading by metabolomics. fructose, blinded and open, and placebo responses will be compared and baseline predictors for a positive breath tests assessed.


Eligibility criteria:
inclusion criteria * thirty male or female fgid (irritable bowel syndrome or functional dyspepsia according to the rome iii criteria) patients - * 10 healthy female and male controls * aged between 18 and 60 years exclusion criteria: * bowel resections, except appendicectomy or cholecystectomy * evidence of organic disease * no medications (excluding antihypertensives, antidepressants and low-dose aspirin), including herbal, from 4 days before the first study day until after breath test * coeliac's disease

Keywords: fructose irritable bowel syndrome breath test placebo
microscopic-spectroscopic examination for urothelial tissue characterization

Conditions: Bladder Tumor

Summary: to evaluate the possibility to properly discriminate between healthy bladder tissue and bca with a multimodal fiber optic spectroscopy (mfos) technique, in order to possibly introduce a more objective way to detect bca, thus reducing inter-observer variability and maybe to determine urothelial carcinoma stage and grade with a comparable accuracy, specificity and sensibility of the current gold standard histopathological analysis

observational single center study on human biological samples to evaluate the possibility to discriminate between healthy and tumor tissue on urothelial bladder samples. aim of the study is to provide a fast, reliable and label free aid/alternative to current histopathology

Eligibility criteria:
inclusion criteria: * willingness to participate, * legal age, * full capacity to sign informed consent * eligibility for each surgical operation according to the best clinical practice and the urological guidelines exclusion criteria: * concomitant use of hexaminolevulinate (hexvix®) * concomitant ongoing utis, * concomitant bladder stone presence, * recent catheterization or persistent bladder catheterization at time of surgery, * concomitant presence of other pelvic cancer (both prostate, urethral, uterine), * previous chemotherapy or radiotherapy of the pelvis, * patient refusal at informed consent.

Keywords: bladdder cancer urothelial tumor pathology spectroscopy bca
role of active valvular calcification and inflammation in patients with aortic stenosis

Conditions: Aortic Stenosis

Summary: the aortic valve is the main outlet valve from the heart. this valve can become diseased and narrowed when it needs to be replaced with an artificial valve. currently, this is the commonest reason for someone to undergo a heart valve operation in the uk. unfortunately, there are no medical treatments that can prevent or delay the progression of this disease process. here, the investigators propose to use new state-of-the-art imaging techniques to better understand the disease process so that the investigators can effectively design and assess potential new treatments. the ultimate aim is to stop this disease before patients need to have surgery. in addition the investigators believe this technique will allow us to predict the rate of progression of the disease

aortic stenosis is the commonest valvular heart disease in the western world and is the leading indication for valve surgery. histological studies have suggested similarities with atherosclerosis including inflammation, lipid deposition, increased macrophage activity and calcification. however, recent randomised controlled trials have failed to demonstrate a reduction in the rate of disease progression with statin therapy and the investigators believe there is now a need to re-evaluate the underlying factors involved in the initiation and progression of aortic stenosis. the investigators propose to assess the role of inflammation and calcification in the pathogenesis and progression of aortic stenosis by using positron emission tomography with \[18f\]-fluorodeoxyglucose and \[18f-\]-fluoride in patients with a range of aortic valve disease. the investigators hypothesise that increasing severity of valvular inflammation and calcification will correlate with disease severity and rate of disease progression. this work will lay the foundation for the subsequent application of interventions targeted at inflammation and calcification.

Eligibility criteria:
inclusion criteria: * age \> 50 years exclusion criteria: * age \< 50 years * life expectancy \< 2 years * insulin dependent diabetes mellitus * connective tissue disorders

Keywords: positron emission tomography inflammation calcification
control of unsupported paraplegic standing

Conditions: Spinal Cord Injury; Stroke

Summary: the study will investigate the feasibility of using functional electrical stimulation (fes) of the calf muscles of paraplegic subjects to assist in posture stabilisation during standing. we aim to achieve postural stability by combining controlled fes of the lower-limb muscles with the voluntary motor control skills of the intact upper body.

aim: the study will investigate the feasibility of using functional electrical stimulation (fes) of the calf muscles of paraplegic subjects to assist in posture stabilisation during standing. we aim to achieve postural stability by combining controlled fes of the lower-limb muscles with the voluntary motor control skills of the intact upper body. background: in spinal cord injury (sci), the paralysed muscles generally retain their ability to contract and electrical stimulation can be used in rehabilitation as a therapy. with functional electrical stimulation (fes) the aim is to restore some normal motor functions such as standing, stepping or cycling. a number of studies have investigated the physiological effects and potential therapeutic benefits of lower-limb fes exercise. these studies have shown that the benefits include restoration of muscle bulk and strength, a reduction in the rate of bone demineralisation, improvements in the range of joint motion, and relaxation of spasm. standing is an important part of rehabilitation therapy for paraplegic patients, and helps to alleviate some of the secondary effects of paralysis.

Eligibility criteria:
inclusion criteria: * neurologically intact, healthy individuals individuals with complete spinal cord lesion between t6 and t12 exclusion criteria: * incomplete sci

Keywords: spinal cord injury standing balance functional electrical stimulation
microneedling for burn hypertrophic scars

Conditions: Burn Scar

Summary: approximately 33 to 91% of severe burn victims will develop hypertrophic scars. hypertrophic scars are defined as erythematous (red), raised and rigid scars that can cause pain and itching, among other things. they cause psychological distress and affect the quality of life of burn victims. microneedling is a technique that uses an electrical device to create hundreds of microchannels that penetrate the skin layers. this study is interested in determining the effectiveness of microneedling in improving the pliability, thickness and erythema of hypertrophic scars. each scar will receive up to 5 acs-pen treatments followed by the application of cortisone (triamcinolone acetonide). knowing that microneedling increases the absorption of products applied to the skin by about 80%, it is logical to think that creating these channels to the dermis and applying cortisone afterwards would have a beneficial effect on the hypertrophic scars of these patients.

patients will receive microneedling once every six weeks for a maximum of five treatments

Eligibility criteria:
inclusion criteria: * any gender or race * 16 years of age or older * have at least 2 hsc that meet the clinical criteria for hsc * provide written informed consent. exclusion criteria: * patients with keloid scars * mature scar site * a psychiatric condition or cognitive impairment that interferes with their ability to follow the treatment protocol * dermatological conditions (i.e. psoriasis, eczema, etc.) in the area of the evaluation site * an allergy to ultrasound gel * on anticoagulant medications * inability to understand english or french.
feasibility, safety, and potential efficacy of fecal microbiota transplantation (fmt) for gastrointestinal dysfunction in children following hematopoietic cell transplant (hct).

Conditions: Gastro-Intestinal Disorder

Summary: the study participant is being asked to take part in this clinical trial, a type of research study, because the participant has gastrointestinal (gi) symptoms following a hematopoietic cell transplant (hct). primary objective * to determine the safety and feasibility of fmt for treating a gvhd of the gut following hct. * to determine the safety and feasibility of fmt for treating hct induced gut dysfunction. secondary objectives * to assess the potential efficacy of fmt for treating a gvhd of the gut following hct. * to assess the potential efficacy of fmt for treating hct induced gut dysfunction.

participants will be eligible to receive an fmt on or after day +30 post-hct. fmt will be performed using fmp material obtained from openbiome. 60 ml of fmp will be administered via nj tube and 250 ml via colonoscopy. a second fmt may be performed at least 14 days after the initial fmt in gi clinical symptoms have partially improved or have not changed. the second fmt will be administered using the same procedure as in the initial fmt

Eligibility criteria:
inclusion criteria: * age \< 22 years old. * received an allogeneic hct greater than or equal to 30 days prior to enrollment * diagnosed with one of the following conditions: 1. steroid-resistant gut a gvhd (defined as gi symptoms that do not improve within 5 days after initial steroid therapy, \>/= 1mg/kg of prednisolone) or 2. steroid-dependent gut a gvhd (defined as the presence of a response to methylprednisolone 2 mg/kg/day but relapsing when an attempt was made to taper steroid treatment). or 3. current or prolonged gi dysfunction following hct, defined as having diarrhea or loose stools \>/= 4 weeks with at least one of the following: 1. requiring ng or g-tube feeds 2. requiring tpn or ivf for more than 4 weeks 3. diagnosis of gastroparesis by gi specialist documented in the medical record * willing and able to provide informed assent/consent exclusion criteria: * cytomegalovirus (cmv) or epstein barr virus (ebv) igg negative at the time of consent * female participant who is pregnant or nursing * history of previous fmt * intra-abdominal surgery within 4 weeks of enrollment * at increased risk for peritonitis: presence of intra-abdominal devices (g-or gj-tubes are acceptable), receiving peritoneal dialysis, or ascites * concurrent abdominal radiation therapy * any acute or chronic illness/condition as well as medication that in the opinion of the investigator puts the subject at greater risk from fmt or may confound the study results.
progenitor cell therapy in dilative cardiomyopathy

Conditions: Heart Failure, Congestive; Cardiomyopathy, Dilated; Stem Cell Transplantation

Summary: intracoronary infusion of bone marrow derived progenitor cells into the lad in patients with non ischemic dilated cardiomyopathy.

initial clinical pilot trials suggested that intracoronary infusion of bone marrow-derived progenitor cells (bmc) may enhance left ventricular functional recovery in patients with acute myocardial infarction. it is unknown, however, whether such a strategy might also be applicable to patients with non-ischemic dilated cardiomyopathy (dcm). therefore, we initiated the topcare-dcm - trial (transplantation of progenitor cells and recovery of left ventricular function in patients with non ischemic dilatative cardiomyopathy) aiming to regionally improve left ventricular contractility by selective infusion of bmc into the left anterior descending coronary artery. patients will be randomized 2:1 (20/10) bmc infusion versus standard medical therapy

Eligibility criteria:
inclusion criteria: * age 8-80 * dilated cardiomyopathy, ejection fraction \< 40% * lvedd \> 60mm * stable clinical condition within last 6 months * written informed consent exclusion criteria: * myocardial infarction or coronary intervention in the past * change of medical therapy within the last 6 weeks prior to cell therapy * tumor within last 5 years or incomplete remission * active infection * active bleeding * stroke within last 2 years * surgery or trauma within last 2 months * uncontrolled hypertension * hiv infection * chronic inflammatory disease * liver disease (got \> 2x upper normal limit) * renal dysfunction (creatinin \> 2.0mg/dl) * thrombopenia \< 100.000 * anemia (hemoglobin \< 8.5 g/dl) * mental retardation
comparison of two apical repair methods in women undergoing repairs for prolapse

Conditions: Pelvic Organ Prolapse; Surgery; Quality of Life; Complication

Summary: to date no study has determined prospectively which technique is superior to prevent recurrent pelvic organ prolapse (pop) after vaginal hysterectomy- a major unmet clinical need. the aim of the study is to determine objective anatomical recurrent prolapse after sacrospinous ligament fixation (slf) vs mccall.

the aim of the study is to determine objective anatomical recurrent prolapse after slf vs mccall. the study is designed as a randomized controlled trial (rct). primary study endpoint will be at 12 months, secondary study endpoint at 24 months. the following parameters will be evaluated after one year: anatomical outcome, quality of life (qol), sexual health, reoperations, and complications.

Eligibility criteria:
inclusion criteria: * declined/ failed conservative treatment for pop * planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated * any symptomatic pop or stage ii prolapse in any compartment * at least stage i prolapse in the apical department * women between 35 and 80 years of age * good german language skills * any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated * concomitant salpingo-oophorectomy if indicated exclusion criteria: * unwillingness to participate * neurological disorders * previous hysterectomy * desire to have children * connective tissue disorders (i.e. ehlers-danlos syndrome, marfan syndrome)
immunogenicity study of an inactivated hepatitis a vaccine in infants and young children

Conditions: Hepatitis A

Summary: infants born to immune mothers and therefore having passively-transferred maternal antibody (pma) to hepatitis a virus (hav) have a blunted immune response to hepatitis a vaccine. we compared the immunogenicity of hepatitis a vaccine among infants with and without pma, vaccinated on different schedules. we found that when vaccination is begun at or after 12 months of age, there was no difference in the immune response to the vaccine between infants born to immune vs. susceptible mothers.

background: infants with passively-transferred maternal antibody (pma) to hepatitis a virus (hav) have a blunted immune response to hepatitis a vaccine. we compared the immunogenicity of hepatitis a vaccine among infants with and without pma, vaccinated on different schedules. methods: infants were randomized to one of three groups, each receiving two doses of 720 el.u. of hepatitis a vaccine (havrix, glaxo smithkline) according to the following schedules: group 1 at ages 6 and 12 months; group 2 at ages 12 and 18 months; group 3 at ages 15 and 21 months. we determined antibody to hav (anti-hav) status of mothers at the time of delivery, and measured infants' anti-hav concentrations at the time of the first vaccine dose (baseline), and at 1, 7 and 12 months thereafter. anti-hav concentrations \> 33 milli-international units/milliliter (miu/ml) were considered protective. we monitored adverse reactions using diary cards and chart reviews. results: a total of 239 infants were enrolled, including 134 born to anti-hav negative mothers (groups 1n, 2n, 3n) and 105 born to anti-hav positive mothers (groups 1p, 2p, 3p). at month 12, 6 months after the second vaccine dose, the difference in gmc between groups 1p and 1n was the only statistically significant difference within groups (p\<0.05). there were no statistically significant differences in gmc among groups of infants born to anti-hav negative mothers ("n" groups), but the difference between group 1p and group 3p infants was significant (p \< 0.05). no serious adverse reactions related to vaccination were detected. conclusions: hepatitis a vaccine is immunogenic among infants born to anti-hav negative mothers, and among those born to anti-hav positive mothers and vaccinated beginning as young as 12 months old. the persistence of pma for at least six months among the majority of infants born to anti-hav positive mothers results in lower seroconversion rates and gmc's.

Eligibility criteria:
inclusion criteria:term infant with normal growth and development, considered to be healthy at age 6 months; written informed consent by parent/guardian - exclusion criteria:received or expected to receive immune globulin or blood/blood products while enrolled; received or expected to receive immunosuppressive therapy within 30 days of vaccination or has immune deficiency; currently enrolled in another vaccine trial; progressive or unstable neurological disorder -

Keywords: hepatitis a hepatitis a vaccine
improving the quality of life of stroke patients using the armeo spring device

Conditions: Ischemic Stroke

Summary: the main goal will be to evaluate the effect of improving the quality of movement of the upper limb (using an evaluation exercise in the software of the armeo spring device) on the development of the quality of life after stroke using a standardized generic and specific questionnaire. the secondary outcome will be to evaluate changes in self-sufficiency using a test of daily activities modified by the frenchay test of daily activities.

the research follows on from a pilot study that took place at the department of rehabilitation and sports medicine, university hospital ostrava from 4/2022 to 9/2022. it has a prospective monocentric randomized trial design. patients will be randomized into parallel groups - intervention and control groups. a prospective monocentric randomized study lasting 8 months at the department of rehabilitation and sports medicine, university hospital ostrava. the study design is parallel with a test and control arm. patients will be divided into an intervention (tested) group a with therapy on armeo spring and a control group b with conventional therapy, using a random number generator, where odd numbers represent arm a and even numbers represent arm b. a randomization table randomly allocates patients to therapy according to their order of entry into the study.

Eligibility criteria:
inclusion criteria: * history of stroke * age over 18 years * modified rankin scale (mrs) of 2-3 * moderate paresis of the upper extremity (individuals with shoulder/elbow muscle test values in the range of 3-1) * cardiovascular stability exclusion criteria: * age under 18 years * severe cognitive or sensory deficit and non-cooperation * severe osteoporosis * impaired skin integrity in the trunk and upper limbs * cardiovascular instability * unstable fractures * acute inflammatory diseases

Keywords: ischemic stroke rehabilitation armeo spring therapy quality of life